GSK’s RSV vaccine approved in EU for older adults

Betsy Goodfellow | June 7, 2023 | News story | Medical Communications EU, GSK, Infections and infestations, RSV, Vaccine 

GSK has announced that the European Commission (EC) has authorised Arexvy, the company’s respiratory syncytial virus (RSV) vaccine for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60 years.

This authorisation marks the first time an RSV vaccine for older adults has received European Marketing Authorisation, with launches planned ahead of the 2023/2024 RSV season which is expected to begin in the autumn.

The vaccine’s approval follows positive data from GSK’s AReSVi-006 phase 3 trial, in which the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults over the age of 60. The efficacy was also 94.6% in older adults with at least one underlying medical condition including cardiorespiratory and endocrine-metabolic conditions.

Tony Wood, chief scientific officer at GSK, commented: “Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation. Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”

Dr Alberto Papi, full professor of respiratory medicine and head at the University of Ferrara, added: “For most, RSV causes cold-like symptoms. For older adults and those with underlying medical conditions however, it can lead to severe disease and is a leading cause of serious respiratory infections. As scientists, we have been trying to find a solution for over 60 years. I am proud to have been part of the innovation that has resulted in a vaccine now being available to help protect eligible older adults across Europe from severe RSV disease for the first time.”

Betsy Goodfellow

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